QA Support Specialist Ii

**Job Title: QA Support Specialist II**

**Location: Woodlands, Singapore**

**Reporting to: QA Support Supervisor**

**About the role**:
This position is part of the Quality Assurance Support team responsible for implementation, maintenance of raw material specifications and release of raw materials, product stability, provide quality oversight to Manufacturing Support, Engineering, Manufacturing Science, Supply Chain and Quality Control to achieve the site objectives for Takeda Singapore.

**How you will contribute**:
**A. Raw Materials**
- Ensure timely release of raw materials for the site to support production.
- Responsible for the development and writing of local raw material specifications.
- Perform assessment for raw material related Supplier Notification.
- Responsible for the development and writing of QA procedures related to raw materials release.
- Management of raw material reference samples.
- Timely archival of incoming release packages and QA Support associated documents.

**B. Stability**
- Act as local SME and coordinator for stability, liaison between global stability team and local stakeholders for product stability program.

**C. Quality Oversight**
- Provide quality oversight by reviewing and approving SOPs related to Manufacturing Support, Engineering, Manufacturing Science, Supply Chain and Quality Control and ensure that it complies with current good documentation practices, applicable global procedures and regulatory requirements.
- Participate in cross-functional investigations
- Participate in alignment meeting with business functions to ensure smooth operations.
- Partner the supporting business functions in the implementation and adherence of the various quality systems and GMP requirements**.**

**D. Other Responsibilities**
- Take on ownership of investigation relating to QA Support
- Provide QA support related impact assessments for change controls and own change controls (relating to QA Support).
- Participate in routine GMP walk through with the relevant operation team.
- Support the compliance, audit, regulatory and training activities as required, and any other duties as assigned by supervisor

**E. Leadership**
- Build strong partnership with all other departments to ensure open communication and acceptance.
- Responsibility to adhere to any applicable EHS requirements.
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.
- Any other duties as assigned by supervisor.

**What you bring to Takeda**:
**Education and Experience Requirements**
- A miniimum experience of 2 years in the pharmaceutical or biotechnology in quality assurance, GMP/GLP compliance, operations or validation, preferably in a multinational company.
- Understanding of FDA/EU and ICH guidelines, any exposure/experience to the international regulatory network/audits will be of advantage.

**Key Skills and Competencies**
- Equip with good knowledge of the quality systems.
- Equip with good knowledge in the various regulatory requirements.
- Equip with raw material release knowledge is preferred.
- Equip with quality requirements for Engineering, Warehouse and Quality Control operations is preferred.
- Able to solve problems in a logical manner to find timely solutions.
- Able to interact and communicate with all types of personalities in an effective and diplomatic manner.

**More about us**:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

**Empowering our people to shine**:

- Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law._

**Locations**:
SGP - Singapore - Woodlands

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time